A market currently exists for apparatuses related to the crushing of certain pill form medications for ease of administration to patients whom have difficulty swallowing medications in pill form. For example, many patients struggle to swallow medications in pill form due to the size and shape of common pills and thus medical staff may resort to crushing the pill and mixing the crushed medication with food or liquid to consume it. Moreover, some patients are completely unable to swallow and rely exclusively on a feeding tube. While the terms “pill,” “capsule,” and “tablet” may have distinct meanings and one skilled in the art may be able to recognize the differences, as used herein the term “pill” is intended to include all three terms and any reasonable equivalents currently known in the field or developed hereafter. Because of this recognized need, a variety of pill crushing devices as well as pill crusher pouches are well-known in the art.
Generally, in order to administer a crushed pill the following steps are performed. First, the pill is placed inside a pill crusher pouch. Second, the pill crusher pouch, with the pill inside, is placed inside a crushing region of a pill crusher device Third, the pill crusher device then exerts a force on the surface of the pouch thereby crushing its contents. Fourth, the now crushed medication is poured from the pill crusher pouch into a beverage which the particles are either dissolved into or suspended within. Finally, the medication is administered by the patient consuming the beverage. There are, however, recognized problems associated with the current state of pill crusher pouches. For example, it is impracticable to extract all of the medication from current pill crusher pouches because particles tend to accumulate in the corners of the pouch and particles also cling to or embed into the pouch material itself. Consequently, the appropriate dosage of medication is not administered. Attempts have been made to solve this problem; however, so far as Applicant is aware no such attempt completely eliminates the problem.
U.S. Pat. No. 7,347,394 to Buckley, dated Mar. 25, 2008, and fully incorporated by reference herein, discloses a pill crusher pouch wherein the closed bottom of the pouch comprises a cup like seal, thus providing a pouch with a corner-less interior to facilitate easier pouring of the pulverized medication from the interior of the pouch. A main design feature of the Buckley pill crusher pouch is the elimination of the sharp pouch corners found in previous pill crusher pouches which is intended to eliminate the accumulation of crushed medication at the corners in order to administer a more complete dose of the crushed medication.
U.S. Pat. No. 7,637,449 to Leyshon et al., dated Dec. 29, 2009, and fully incorporated by reference herein, discloses a pill crusher pouch having a slanted bottom adapted to direct crushed medication toward a focal point along the bottom and at least one perforation line intersecting the bottom slightly above the focal point. In order to dispense the crushed medication, the portion of the pill crusher pouch below the perforation is torn to create a funnel-like structure which guides the crushed medication to the desired location.
While many pill crusher pouches, such as those described supra, comprise geometrical optimizations as a means of facilitating more complete extraction of a crushed medication, an amount of crushed particle may become embedded in or even cling to the flat inner surfaces of the pouch. Therefore, so long as a crushed medication is poured from a pill crusher pouch it cannot be guaranteed that one hundred percent of the medication will be extracted and administered. In this regard, there is a need for a new and improved pill crusher pouch that allows the whole of a crushed pill to be consumed by a patient.
In addition to improper dosage administration, the crushing of some pills creates particles which are small enough to be carried through the air, an effect known as aerosolization. Aerosolized particles can then be inhaled through the lungs of caregivers or patients or both. With certain medications, aerosolization and inhalation has seriously adverse health effects. The problem of inadvertent aerosolization is exacerbated when a drug is poured from a pill crushing bag, e.g. into a food or liquid prior to administration. E.g., tamoxifen is a cytotoxic drug routinely used in the management of breast cancer which can be dangerous to caregivers if inhaled. Anthony James et al., The legal and clinical implications of crushing tablet medication, Nursing Times, Vol. 100, no. 50 (Dec. 14, 2004), p. 28. Moreover, some medications require special handling considerations by patients and caregivers because of their potentially deleterious effects to those who come into inadvertent contact with the drug. E.g., mycophenolate (CellCept®) is an immunosuppressant used for organ transplant patients which acts as a carcinogen (cancer-causing agent) if it comes into contact with the skin; and finasteride (Proscar®, also marketed as Propecia®) is a drug used to treat prostate enlargement and male pattern baldness which has teratogenic properties and should not be touched by women of childbearing age. Donna Gill, DNP et al., Crushing and Splitting Medications Unrecognized Hazards, Journal of Gerontological Nursing, Vol. 38, no. 1 (January 2012), pp. 8-12. Many medications which can have deleterious effects if inadvertently contacted are manufactured in pill form with a protective coating to prevent contact with the medication during handling and, ultimately, to reduce the risk of harming those handling the drug. Crushing such pills obviously destroys their protective coatings. The problems associated with inadvertent contact and aeresolization have been recognized by health organizations including the National Institute for Occupational Safety and Health (NIOSH) and, in regard to these problems, there is a need for a new and improved pill crusher pouch that prevents both the aerosolization of the crushed medication as well as other types of inadvertent contact that may result from the crushing and administering a medication originally in pill form.
Even beyond the problems of inhalation after aerosolization and other inadvertent contact with medications, other problems associated with the crushing of certain medications remain. In fact, many pills have specific properties designed into the pill structure that go beyond simply the type of medication contained therein, and crushing such pills often destroys these desirable properties. For example, extended release medications, i.e. pills specifically designed to dissolve a medication over time in order for it to be released slower and steadier into the bloodstream while having the advantage of being taken at less frequent intervals than immediate-release formulations of the same drug, often contain a higher dosage than their immediate release counterparts. If these drugs are crushed they lose their ability to slow the rate at which the medication is absorbed into the patient's bloodstream. Therefore, the improper crushing of an extended release medication results in a higher dosage of medication being administered and can have deleterious consequences because the pharmacokinetic and pharmacodynamic properties will be unpredictable and inconsistent. Categories of extended release (ER) medication (and their associated prefix or suffix) which lose their desirable properties if crushed include continuous release (CC), controlled dose (CD), controlled release (CR), long acting (LA), slow action (Retard), slow release (Slo-), sustained action (SA), and sustained release (SR). In addition to extended release medications, the following should not be crushed prior to administration: enteric or protected coating medications designed to dissolve in the intestines; medications formulated for sublingual (under the tongue) or buccal (between the cheek and gums) administration; and those designed to exert a local effect in the mouth. In regard to the aforementioned problems, there is a need for a medication administration bag that mitigates the risk of health care professionals crushing medications for ease of patient consumption when said medications are of a type unsuitable for being crushed.
Accordingly, this application discloses a dissolvable medication administration bag that meets the needs recognized supra. The dissolvable medication administration bag may be utilized in the form of a dissolvable pill crusher pouch that allows for the whole of a crushed pill to be consumed by the patient and that also prevents inadvertent contact with the crushed medication, i.e. both direct contact and inhalation after aerosolization are prevented. In such an embodiment, after a medication has been crushed inside the pouch the entirety of the pouch and its contents are placed in a liquid into which both the pouch and its contents fully dissolve. Additionally, the dissolvable medication administration bag may be utilized in the form of a pre-packaged dissolvable medicine dosage administration bag that allows for health care professionals to dissolve certain allowable medications into a beverage or the nutritional contents of a feeding tube for ease of administration while mitigating the risk of destroying desirable properties specifically designed into the pill structure. In such an embodiment, the medication may be pre-measured and pre-packaged in a controlled environment, e.g. in a manufacturing facility or in a pharmacy by a licensed pharmacist, so that there is no confusion at the place of administration as to which medications may be dissolved into a beverage or feeding tube supply for ease of administration.
All references cited herein are incorporated herein by reference in their entireties.